Analysis device, and analysis apparatus and method using the same

ABSTRACT

A protective cap  2  is engaged with a latch  10  of a diluent container  5  so as to fix the diluent container  5  at a liquid holding position of a diluent container containing section  11 . The engagement is released when the protective cap  2  is set to an open position against the engagement so as to expose an inlet  13 . When the protective cap  2  is shifted from the open position to a closed position, the protective cap  2  pushes the diluent container  5  into a liquid discharge position. Thus, it is possible to preserve a diluent for a long period of time and to easily open the diluent container  5  without having to complicate the structure of an analysis apparatus.

TECHNICAL FIELD

The present invention relates to an analysis device to be used toanalyze a liquid collected from a living organism or the like, and to ananalysis apparatus and an analysis method using the same. Morespecifically, the present invention relates to a technique of opening adiluent container holding a diluent for diluting a sample liquid withinan analysis device.

BACKGROUND ART

Conventionally, as a method of analyzing a liquid collected from aliving organism or the like, an analysis method is known that uses ananalysis device in which a liquid channel is formed. The analysis deviceis capable of controlling a fluid using a rotating apparatus. Since theanalysis device is capable of performing dilution of a sample liquid,solution measurement, separation of solid components, transfer anddistribution of a separated fluid, mixing of a solution and a reagent,and the like by utilizing centrifugal force, various biochemicalanalyses can be carried out.

In particular, while the dilution of a sample liquid is a necessaryprocess when analyzing a minute sample, having to inject a requiredamount of diluent into an analysis device from the outside every time ameasurement is to be performed is not user-friendly. Therefore,configurations are considered in which a diluent container holding adiluent is contained, in advance, in an analysis device and the diluentcontainer can be readily opened.

In the case of an analysis device described in Patent Document 1(National Publication of International Patent Application No. 07-503794)which dilutes a sample liquid to perform analysis, as illustrated inFIG. 51A, a diluent container 51 is contained in a chamber 50 in theanalysis device. The diluent container 51 includes a thin-film seal 52and a rigid side section 54 having a scribed mark 53. The diluentcontainer 51 is held at a predetermined position by a holding post 55.FIG. 51B illustrates a state where a spindle or a post 56 has enteredthe chamber 50 through a receiving hole 57. At this position, the post56 moves the diluent container 51 towards a receiving chamber 58 whilethe rigid side section 54 splits along the scribed mark 53 so as to forman opening 59. A diluent held in the diluent container 51 flows out dueto the rotation of a rotor and is transferred into the receiving chamber58 via an exit channel 60. The receiving chamber 58 is a mixing chamberin which a sample liquid and the diluent are mixed.

In addition, an analysis device described in Patent Document 2 (JapanesePatent Laid-Open No. 03-046566) is configured such that a liquid supplyreservoir 62 is contained in an analysis device main body 61 asillustrated in FIG. 52. A liquid reagent 63 held in the liquid supplyreservoir 62 is introduced into a reaction path 66 by pulling a terminal65 of a film 64. Subsequently, due to gravity, the liquid reagent 63freely flows into a corner 68 of the reaction path 66 along a pathdepicted by a dashed arrow 67. A sample is retrieved by an operation ofintroducing a capillary holder 69 into the analysis device main body 61.Reference numerals 70, 71, and 72 denote reagents.

An analysis device 50B described in Patent Document 3 (NationalPublication of International Patent Application No. 07-500910) whichtransfers a solution utilizing centrifugal force is arranged so as toinject a sample liquid into a measuring chamber 52B from an inlet 51Bwith an insertion tool such as a pipette as illustrated in FIG. 53, andafter holding the sample liquid by a capillary force of the measuringchamber 52B, transfer the sample liquid to a separation chamber 53B bythe rotation of the analysis device 50B. Providing such an analysisdevice which uses centrifugal force as a power source for liquidtransfer with a disk-like shape enables microchannels for liquidtransfer control to be arranged radially. Since no wasted area iscreated, the disk-like shape is used as a favorable shape.

A configuration illustrated in FIGS. 26 and 27 is conceivable as ananalysis device driving apparatus that rotationally drives a detachablyset analysis device 50B.

As illustrated in FIG. 26, an analysis device 1 in which is set a sampleliquid is set on a rotor 101. With a door 103 closed, the analysisdevice 1 is sandwiched using a clamper 116. By rotationally moving therotor 101, the sample liquid is transferred inside the analysis device 1and is then analyzed or centrifugally separated.

FIG. 27 illustrates a state where the analysis device 1 is set on therotor 101 and the door 103 is closed. In FIG. 27, the door 103rotationally moves around a support shaft 114 and is openable andclosable.

A groove 102 is formed on an upper face of the rotor 101. When theanalysis device 1 is set on the rotor 101, an engaging section 15 of theanalysis device 1 is engaged with the groove 102. When the analysisdevice 1 is set on the rotor 101 and the door 103 is closed beforerotating the rotor 101, the clamper 116 provided on a side of the door103 pushes a position of the set analysis device 1 on the rotation axialcenter of the rotor 101 towards the rotor 101 using a biasing force of aspring 105, thereby causing the analysis device 1 to integrally rotatewith the rotor 101 that is rotationally driven by a rotational drivingunit 106. Reference numeral 107 denotes an axial center during rotationof the rotor 101.

Blood contained in a sample liquid remains on a used analysis device.Therefore, a risk of infection exists when the protective cap 2 isdeliberately opened.

With respect to liquid storage containers for food, hygiene products,fuel, medicinal substances such as pesticides, and the like, andcontainers with lids such as in-store display cases for rental videosand the like, as seen in Patent Document 4 (Japanese Patent No.3202662), various containers with lock functions which prevent the lidsof the containers from being inadvertently or intentionally opened arebeing provided.

-   Patent Document 1: National Publication of International Patent    Application No. 07-503794-   Patent Document 2: Japanese Patent Laid-Open No. 03-046566-   Patent Document 3: National Publication of International Patent    Application No. 07-500910-   Patent Document 4: Japanese Patent No. 3202662

DISCLOSURE OF THE INVENTION Problems to be Solved by the Invention

However, in Patent Document 1, the thickness of the container at theportion of the scribed mark 53 is reduced and the moisture permeabilityof the diluent container 51 is increased in order to make the diluentcontainer 51 more readily breakable. In addition, since a resin memberhaving rigidity must also be used for the thin-film seal 52, themoisture permeability of the seal portion increases. Therefore, adiluent inside the diluent container 51 cannot be preserved for a longperiod of time, resulting in variations in liquid volume and reagentconcentration which affect measurement accuracy. Moreover, the necessityof providing the analysis apparatus with a mechanism for operating thepost 55 disadvantageously complicates the structure and increases thecost of the apparatus.

In addition, in Patent Document 2, operations to be performed by a userbefore setting the analysis device to an analysis apparatus includes: anoperation of collecting a sample liquid with a sample collectingcapillary 73 of the capillary holder 69; an operation of introducing thecapillary holder 69 into the analysis device main body 61; and anoperation of pulling the film 64 of the liquid supply reservoir 62. Thisresults in low operability for a user and creates a risk of erroneousoperations. Furthermore, since the film 64 must be peeled off anddiscarded, the amount of waste as well as the burden on a userdisadvantageously increase.

The present invention has been made to solve such conventional problems,and an object thereof is to provide an analysis device capable ofpreserving a diluent over a long period of time and enabling a diluentcontainer to be easily opened without having to complicate the structureof an analysis apparatus, and an analysis apparatus and an analysismethod using the analysis device.

In addition, with the configuration illustrated in FIG. 27, when anexternal force such as a vibration or an impact shock acts on theanalysis device 1 during high-speed rotation, a failure occurs in whichthe analysis device 1 is uplifted and becomes detached from the rotor101.

An object of the present invention is to provide a safe analysis devicedriving apparatus capable of avoiding the occurrence of a failure inwhich an analysis device detaches from a rotor during high-speedrotation and the like even when an external force acts during operation.

Furthermore, the configuration according to Patent Document 4 enables alocking mechanism to be released relatively easily and a lid to berepetitively opened and closed. As a result, there is a risk ofoccurrence of a serious accident when the lid is reopened such as theinclusion of a liquid such as blood which has a risk of secondaryinfection or a contaminant or, in a case of disposal of a used chemicalsuch as a pesticide, contamination or secondary infection due to thereuse of the used chemical.

The present invention has been made in order to solve the conventionalproblems described above, and an object thereof is to provide a liddedcontainer including a locking mechanism capable of preventing thereopening of a lid.

Means for Solving the Problems

An analysis device according to the present invention is an analysisdevice having a microchannel structure that transfers a sample liquidtowards a measurement spot by centrifugal force and which is used forreading involving accessing a reaction liquid at the measurement spot,the analysis device including: an analysis device main body having,formed inside, a microchannel structure with minute surfaceirregularities; a protective cap that exposes, in an open position, aninlet for collecting a sample liquid into the microchannel structure,and in a closed position, covers a part of the analysis device main bodyand prevents scattering of the sample liquid from the inlet; a diluentcontainer whose opening is sealed by a seal member so as to internallyhold a diluent; a diluent container containing section formed inside theanalysis device main body and which contains the diluent container so asto be movable between a liquid holding position and a liquid dischargeposition; and a protrusion provided so as to protrude along a movementpath of the diluent container from the liquid holding position to theliquid discharge position in the diluent container containing sectionand which breaks the seal member of the diluent container having movedto the liquid discharge position so as to open the diluent container,wherein the diluent container is moved to the open position where theseal member engages the protrusion to be broken by a shifting of theprotective cap from the open position to the closed position, and thediluent container and a part of the protective cap at the closedposition before moving to the open position to expose the inlet are indirect or indirect engagement with each other so as to lock the diluentcontainer to the liquid holding position and prevent the diluentcontainer from moving to the liquid discharge position.

In addition, an analysis device according to the present inventionfurther includes: a latch provided on the diluent container on a side ofthe protective cap, wherein the diluent container and the protective capat the closed position before moving to the open position to expose theinlet are in engagement with the latch of the diluent container so as tolock the diluent container to the liquid holding position of the diluentcontainer containing section, the engagement of the latch of the diluentcontainer and the protective cap is released by setting the protectivecap to the open position against the engagement and exposing the inlet,and when closing the protective cap from the open position to the closedposition, the protective cap abuts on a face of the latch of the diluentcontainer on a side of the protective cap so as to push the diluentcontainer into the liquid discharge position.

Furthermore, in an analysis device according to the present invention, aseal face on which the seal member of the diluent container is to beapplied is obliquely formed.

Moreover, the analysis device main body includes: a hole provided so asto enable a locking jig to protrude along the movement path; and agroove provided on any of an upper face and a lower face of the diluentcontainer and which locks the diluent container when the locking jigengages the diluent container through the hole at the liquid holdingposition.

In addition, a bottom of the diluent container that is on a sideopposite to an opening sealed by the seal member is formed by an arcface.

An analysis apparatus according to the present invention is an analysisapparatus in which is set an analysis device including: an analysisdevice main body having, formed inside, a microchannel structure withminute surface irregularities; a protective cap that exposes, in an openposition, an inlet for collecting a sample liquid into the microchannelstructure, and in a closed position, covers a part of the analysisdevice main body and prevents scattering of the sample liquid from theinlet; a diluent container whose opening is sealed by a seal member soas to internally hold a diluent; a diluent container containing sectionformed inside the analysis device main body and which contains thediluent container so as to be movable between a liquid holding positionand a liquid discharge position; and a protrusion provided so as toprotrude along a movement path of the diluent container from the liquidholding position to the liquid discharge position in the diluentcontainer containing section and which breaks the seal member of thediluent container having moved to the liquid discharge position so as toopen the diluent container, the diluent container to be moved to theopen position where the seal member engages the protrusion to be brokenby a shifting of the protective cap from the open position to the closedposition, and the diluent container and a part of the protective cap atthe closed position before moving to the open position to expose theinlet are in direct or indirect engagement with each other so as to lockthe diluent container to the liquid holding position and prevent thediluent container from moving to the liquid discharge position, whereinthe analysis apparatus includes a rotation driving unit that rotates andstops the analysis device around an axial center so as to transfer thesample liquid and the diluent discharged from the diluent container to ameasurement chamber, and an analysis unit that accesses and analyzes asolution in the measurement chamber.

An analysis method according to the present invention is an analysismethod using an analysis device including: an analysis device main bodyhaving, formed inside, a microchannel structure with minute surfaceirregularities; a protective cap that exposes, in an open position, aninlet for collecting a sample liquid into the microchannel structure,and in a closed position, covers a part of the analysis device main bodyand prevents scattering of the sample liquid from the inlet; a diluentcontainer whose opening is sealed by a seal member so as to internallyhold a diluent; a diluent container containing section formed inside theanalysis device main body and which contains the diluent container so asto be movable between a liquid holding position and a liquid dischargeposition; and a protrusion provided so as to protrude along a movementpath of the diluent container from the liquid holding position to theliquid discharge position in the diluent container containing sectionand which breaks the seal member of the diluent container having movedto the liquid discharge position so as to open the diluent container,the diluent container to be moved to the open position where the sealmember engages the protrusion to be broken by a shifting of theprotective cap from the open position to the closed position, and thediluent container and a part of the protective cap at the closedposition before moving to the open position to expose the inlet are indirect or indirect engagement with each other so as to lock the diluentcontainer to the liquid holding position and prevent the diluentcontainer from moving to the liquid discharge position, wherein theanalysis method includes: spot-applying the sample liquid onto the inletexposed by opening the protective cap of the analysis device andcollecting the sample liquid, pushing the diluent container set in thediluent container containing section of the analysis device towards theprotrusion provided so as to protrude along the movement path of thediluent container from the liquid holding position to the liquiddischarge position of the diluent container containing section by anoperation of the protective cap from the open position to the closedposition, and pressing the seal member of the diluent container againstthe protrusion so as to break the seal member and open the diluentcontainer; setting the analysis device opened by breaking the sealmember onto a rotor having an axial center and rotating the rotor so asto dilute at least a portion of the sample liquid spot-applied to theanalysis device by the diluent discharged from the diluent container;and accessing and analyzing a solution component diluted by the diluentor a reactant of a solution component diluted by the diluent and areagent.

An analysis device driving apparatus according to the present inventionis an analysis device driving apparatus that sets an analysis device inwhich a sample liquid is set onto a rotor and rotationally moves therotor to transfer the sample liquid in the analysis device so as toanalyze or centrifugally separate the sample liquid, wherein theanalysis device driving apparatus includes: a clamper that sandwichesthe analysis device with the rotor; a biasing unit that presses theclamper in a direction approaching the rotor; and a stopper unitpositioned on an axial center of the clamper in a state where theclamper and the rotor are sandwiching the analysis device and whichabuts and regulates the analysis device from detaching from the rotoronly when the clamper uplifts from the rotor against a biasing force ofthe biasing unit beyond a permissible value.

In addition, an analysis device driving apparatus according to thepresent invention includes a door that is opened or closed whenattaching or detaching the analysis device to/from the rotor, whereinthe biasing unit is made up of a flat spring that is longitudinallydisposed in a radial direction of the rotor and whose tip abuts to anaxial center of the clamper, and a protrusion provided on an inner faceof the door as the stopper unit and having a height that abuts to theaxial center of the clamper via the flat spring when the clamper upliftsfrom the rotor against a biasing force of the flat spring beyond apermissible value.

Furthermore, an analysis device driving apparatus according to thepresent invention is an analysis device driving apparatus that sets ananalysis device in which a sample liquid is set onto a rotor androtationally moves the rotor to transfer the sample liquid in theanalysis device so as to analyze or centrifugally separate the sampleliquid, the analysis device driving apparatus including: a clamper thatsandwiches the analysis device with the rotor; a holding plate having ahole through which the clamper is inserted and which engages andsupports the clamper in a stand-by state where the clamper and the rotorare not sandwiching the analysis device, and whose engagement with theclamper is released in a state where the clamper and the rotor aresandwiching the analysis device; and a biasing unit that presses theclamper in a direction approaching the rotor, wherein a gap between aface of the holding plate on a side of the rotor and a face that opposesthe clamper in a state where the rotor and the clamper are sandwichingthe analysis device is set to an abutting distance only when the clamperuplifts from the rotor against a biasing force of the biasing unitbeyond a permissible value.

Moreover, an analysis device driving apparatus according to the presentinvention has a protrusion formed so as to protrude towards the clamperaround the hole on a rotor-side face of the holding plate.

In addition, an analysis device driving apparatus according to thepresent invention has a protrusion formed so as to protrude towards theclamper on a face of the clamper opposing the holding plate.

An analysis device according to the present invention includes: ananalysis device main body having, formed inside, a microchannelstructure with minute surface irregularities; a protective cap thatcovers protection object locations of the analysis device main body; ahooked portion formed on one of the analysis device main body and theprotective cap; and a locking piece formed in correspondence to thehooked portion on the other of the analysis device main body and theprotective cap, wherein in a state where the protective cap is firstmoved to a position where the protection object locations of theanalysis device main body are exposed and subsequently returned to aposition where the protection object locations of the analysis devicemain body are covered, the hooked portion engages the locking piece soas to prevent the protective cap from moving to the position where theprotection object locations of the analysis device main body areexposed.

In addition, in an analysis device according to the present invention,an end of the protective cap is pivotally supported by the analysisdevice main body so as to be rotationally movable between the positionwhere the protection object locations of the analysis device main bodyare covered and the position where the protection object locations ofthe analysis device main body are exposed, the locking piece is providedon a primary face of the analysis device main body, and the hookedportion is provided on a primary face of the protective cap.

Furthermore, in an analysis device according to the present invention,an end of the protective cap is pivotally supported by the analysisdevice main body so as to be rotationally movable between the positionwhere the protection object locations of the analysis device main bodyare covered and the position where the protection object locations ofthe analysis device main body are exposed, the locking piece is providedon a peripheral face adjacent to a primary face of the analysis devicemain body, and the hooked portion is provided on a peripheral faceadjacent to a primary face of the protective cap.

Moreover, in an analysis device according to the present invention,protection object locations of the analysis device main body arearranged in an exposed state so as to be detachable by sliding theprotective cap set at a position covering the protection objectlocations along a sliding face between the analysis device main body andthe protective cap, the hooked portion is provided on a face along thesliding face of one of the analysis device main body and the protectivecap, and the locking piece is provided on a face along the sliding faceof the other of the analysis device main body and the protective cap.

Advantages of the Invention

With an analysis device according to the present invention and ananalysis apparatus and an analysis method using the analysis device,since a diluent container can be opened by a minimal operation by a userfor collecting a sample liquid and a diluent can be automaticallytransferred into the analysis device, analytical precision can beimproved, analysis apparatuses can be simplified, cost can be reduced,and user operability can be improved.

With an analysis device driving apparatus and an analysis apparatusincluding the analysis device driving apparatus according to the presentinvention, since a stopper unit abuts on an axial center of a rotatingclamper even when the clamper attempts to uplift beyond a permissiblevalue due to an external force that acts during operation, the analysisdevice is prevented from detaching from a rotor.

With a lidded container using a reuse-preventing locking mechanismaccording to the present invention, since a lid member (protective cap)is locked and prevented from reopening by a simple lid opening/closingoperation performed by a user, used containers can now be readilydistinguished. Furthermore, by making it difficult to accidentally reuseused containers, syringes, and the like, it is now possible to preventaccidents such as infection or contamination from blood and the like.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an external perspective view of a state where a protectivecap of an analysis device according to an embodiment of the presentinvention is closed;

FIG. 1B is an external perspective view of a state where a protectivecap of an analysis device according to an embodiment of the presentinvention is opened;

FIG. 2 is an exploded perspective view of an analysis device accordingto an embodiment of the present invention;

FIG. 3 is a perspective view of an analysis device in a state where aprotective cap is closed as seen from behind;

FIG. 4 is a plan view, an A-A cross-sectional view, a side view, a rearview, and a front view of a diluent container according to an embodimentof the present invention;

FIG. 5 is a plan view, a B-B cross-sectional view, a side view, a rearview, and a front view of a protective cap according to an embodiment ofthe present invention;

FIG. 6 is a cross-sectional view of an analysis device according to anembodiment of the present invention before use, a cross-sectional viewof an analysis device when spot-applying a sample liquid, and across-sectional view of an analysis device when a protective cap isclosed after having finished spot-applying the sample liquid;

FIG. 7 is a perspective view taken immediately before setting ananalysis device onto an analysis apparatus;

FIG. 8 is a cross-sectional view of a state where an analysis device hasbeen set on an analysis apparatus;

FIG. 9 is a configuration diagram of an analysis apparatus according toan embodiment of the present invention;

FIG. 10A is an enlarged perspective view of substantial parts of ananalysis device according to an embodiment of the present invention;

FIG. 10B is an enlarged explanatory diagram of a base substrate that isa substantial part of an analysis device according to an embodiment ofthe present invention;

FIG. 10C is a cross-sectional view of substantial parts of an analysisdevice according to an embodiment of the present invention;

FIG. 11 is a cross-sectional view taken after setting an analysis deviceon an analysis apparatus and before starting rotation;

FIG. 12 is a cross-sectional view taken after setting an analysis deviceon an analysis apparatus and rotating the same, and a cross-sectionalview taken after centrifugal separation;

FIG. 13 is an enlarged cross-sectional view illustrating an axial centerof rotation of an analysis device and a position of a diluent containerat a timing where a diluent is discharged from the diluent container;

FIG. 14 is a cross-sectional view taken when quantitatively collecting asolid component of a sample liquid after centrifugal separation, and across-sectional view taken when diluting the solid component of thesample liquid after centrifugal separation;

FIG. 15A is an enlarged plan view of substantial parts;

FIG. 15B is an enlarged plan view of a measurement holding state;

FIG. 15C is an enlarged perspective view of substantial parts;

FIG. 16 is a cross-sectional view of a process for setting to a shippingstate;

FIG. 17 is a cross-sectional view of a state where an analysis device isset in an analysis apparatus according to a second embodiment of thepresent invention;

FIG. 18 is a perspective view of a state where a door of an analysisapparatus according to the second embodiment of the present inventionhas been opened;

FIG. 19A is an enlarged cross-sectional view taken immediately beforesetting an analysis device onto a rotor;

FIG. 19B is an enlarged cross-sectional view of a state where ananalysis device has been set on a rotor;

FIG. 20 is a cross-sectional view of a state where an analysis device isset in an analysis apparatus according to a third embodiment of thepresent invention;

FIG. 21 is a cross-sectional view of a state where an analysis device isset in an analysis apparatus according to a fourth embodiment of thepresent invention;

FIG. 22 is a cross-sectional view of a state where an analysis device isset in an analysis apparatus according to a fifth embodiment of thepresent invention;

FIG. 23 is a cross-sectional view of a state where an analysis device isset in an analysis apparatus according to a sixth embodiment of thepresent invention;

FIG. 24 is a cross-sectional view of a state where a leading end of ananalysis device is inserted into an insertion opening of an analysisapparatus according to a seventh embodiment of the present invention;

FIG. 25A is a cross-sectional view before a turntable rises in a processof sandwiching an analysis device according to the seventh embodiment ofthe present invention;

FIG. 25B is a cross-sectional view after a turntable rises in a processof sandwiching an analysis device according to the seventh embodiment ofthe present invention;

FIG. 26 is a perspective view of a state where a door of an analysisapparatus has been opened;

FIG. 27 is a cross-sectional view of a state where an analysis devicehas been set on an analysis device driving apparatus;

FIG. 28 is a perspective view of an in-use state in which a protectivecap of a lidded container according to an eighth embodiment of thepresent invention has been opened;

FIG. 29 is a cross-sectional view of FIG. 18;

FIG. 30 is a cross-sectional view taken during an analysis performed byan analysis apparatus;

FIG. 31 is a perspective view of an unused state of a lidded containeraccording to the eighth embodiment of the present invention;

FIG. 32 is an enlarged view of substantial parts illustrated in FIG. 31;

FIG. 33A is an enlarged view of substantial parts before opening aprotective cap of a lidded container according to the eighth embodimentof the present invention;

FIG. 33B is an enlarged view of substantial parts when a protective capof a lidded container according to the eighth embodiment of the presentinvention is being opened;

FIG. 33C is an enlarged view of substantial parts when a protective capof a lidded container according to the eighth embodiment of the presentinvention is being opened;

FIG. 34A is an enlarged view of substantial parts when a protective capof a lidded container according to the eighth embodiment of the presentinvention is being closed;

FIG. 34B is an enlarged view of substantial parts when a protective capof a lidded container according to the eighth embodiment of the presentinvention is being closed;

FIG. 34C is an enlarged view of substantial parts after closing aprotective cap of a lidded container according to the eighth embodimentof the present invention;

FIG. 35 is a perspective view of an in-use state in which a protectivecap of a lidded container according to a ninth embodiment of the presentinvention has been opened;

FIG. 36 is a perspective view of an unused state of a lidded containeraccording to the ninth embodiment of the present invention;

FIG. 37 is an exploded perspective view of a lidded container accordingto the ninth embodiment of the present invention;

FIG. 38 is an A cross-sectional view of FIG. 37;

FIG. 39 is an enlarged view of substantial parts illustrated in FIG. 36;

FIG. 40 is an enlarged plan view of substantial parts in an unused stateof a lidded container according to the ninth embodiment of the presentinvention;

FIG. 41A is an enlarged view of substantial parts when a protective capof a lidded container according to the ninth embodiment of the presentinvention has been opened and is now being closed;

FIG. 41B is an enlarged view of substantial parts when a protective capof a lidded container according to the ninth embodiment of the presentinvention has been opened and is now being closed;

FIG. 41C is an enlarged view of substantial parts when a protective capof a lidded container according to the ninth embodiment of the presentinvention has been opened and is now closed;

FIG. 42 is an enlarged perspective view of substantial parts accordingto a tenth embodiment of the present invention;

FIG. 43 is an enlarged plan view of substantial parts according to thetenth embodiment of the present invention;

FIG. 44A is an enlarged view of substantial parts after opening andduring closing according to the tenth embodiment of the presentinvention;

FIG. 44B is an enlarged view of substantial parts after opening andduring closing according to the tenth embodiment of the presentinvention;

FIG. 44C is an enlarged view of substantial parts after opening andclosing according to the tenth embodiment of the present invention;

FIG. 45 is a perspective view of an in-use state in which a protectivecap of a lidded container according to an eleventh embodiment of thepresent invention has been opened;

FIG. 46 is a perspective view of an unused state of a lidded containeraccording to the eleventh embodiment of the present invention;

FIG. 47 is an enlarged view of substantial parts during a process ofopening a protective cap of a lidded container according to the eleventhembodiment of the present invention;

FIG. 48 is an enlarged view of substantial parts during a process ofclosing a protective cap of a lidded container according to the eleventhembodiment of the present invention;

FIG. 49 is a perspective view of an after-use state of a liddedcontainer according to the eleventh embodiment of the present invention;

FIG. 50 is a perspective view of substantial parts of a lidded containeraccording to a twelfth embodiment of the present invention;

FIG. 51A is a plan view taken before opening a diluent container of ananalysis device according to Patent Document 1;

FIG. 51B is a plan view taken after opening a diluent container of ananalysis device according to Patent Document 1;

FIG. 52 is a cross-sectional view taken when opening a diluent containerof an analysis device according to Patent Document 2; and

FIG. 53 is a partial cutaway perspective view of an analysis deviceaccording to Patent Document 3.

BEST MODE FOR CARRYING OUT THE INVENTION First Embodiment

First, a description will be given with reference to FIGS. 1 to 16 on ananalysis device capable of preserving a diluent over a long period oftime and easily opening a diluent container without having to complicatethe structure of an analysis apparatus, and an analysis apparatus and ananalysis method using the analysis device.

FIGS. 1 to 6 illustrate an analysis device.

FIGS. 1A and 1B respectively illustrate a closed state and an openedstate of a protective cap 2 of an analysis device 1. FIG. 2 illustratesan exploded state when a lower side as illustrated in FIG. 1A is facedupwards. FIG. 3 is an assembly diagram of the same.

As illustrated in FIGS. 1 and 2, the analysis device 1 is made up offour parts including: a base substrate 3 with one face on which isformed a microchannel structure having minute irregularities on asurface thereof; a cover substrate 4 for covering a surface of the basesubstrate 3; a diluent container 5 holding a diluent; and a protectivecap 2 for preventing scattering of a sample liquid.

The base substrate 3 and the cover substrate 4 are bonded in a statewhere the diluent container 5 and the like are internally set, wherebythe protective cap 2 is attached to the base substrate 3 and the coversubstrate 4 in the bonded state.

By covering the openings of the several depressions formed on the upperface of the base substrate 3 with the cover substrate 4, a plurality ofcontainment areas to be described later (the same as the measurementspots to be described later) and channels having microchannel structureswhich interconnect the containment areas are formed. Among thecontainment areas, those required hold, in advance, reagents necessaryfor performing various analyses. One side of the protective cap 2 ispivotally supported so as to be capable of engaging shafts 6 a and 6 bformed on the base substrate 3 and the cover substrate 4 and to beopenable and closable. When a sample liquid to be tested is blood, gapsbetween respective channels with microchannel structures in whichcapillary force acts are set to 50 μm to 300 μm.

An analysis process using the analysis device 1 described above can besummarized as spot-applying a sample liquid to the analysis device 1 inwhich a diluent has been set in advance, and performing measurementafter diluting at least a portion of the sample liquid with the diluent.

FIG. 4 illustrates shapes of the diluent container 5.

FIG. 4A is a plan view; FIG. 4B is a cross-sectional view taken alongA-A in FIG. 4A; FIG. 4C is a side view; FIG. 4D is a rear view; and FIG.4E is a front view as seen from an opening 7. The opening 7 is sealed byan aluminum seal 9 as a seal member after filling an inside 5 a of thediluent container 5 with a diluent 8 as illustrated in FIG. 6A. A latch10 is formed on a side of the diluent container 5 opposite to theopening 7. The diluent container 5 is set in and contained by a diluentcontainer containing section 11 formed between the base substrate 3 andthe cover substrate 4 so as to be movable to a liquid holding positionillustrated in FIG. 6A and a liquid discharge position illustrated inFIG. 6C.

FIG. 5 illustrates shapes of the protective cap 2.

FIG. 5A is a plan view; FIG. 5B is a cross-sectional view taken alongB-B in FIG. 5A; FIG. 5C is a side view; FIG. 5D is a rear view; and FIG.5E is a front view as seen from an opening 2 a. As illustrated in FIG.6A, a locking groove 12 with which the latch 10 of the diluent container5 can engage in a closed state illustrated in FIG. 1A is formed on aninner side of the protective cap 2.

FIG. 6A illustrates the analysis device 1 prior to use. In this state,the protective cap 2 is closed and the latch 10 of the diluent container5 is in engagement with the locking groove 12 of the protective cap 2 soas to lock the diluent container 5 at the liquid holding position andprevent the diluent container 5 from moving in a direction depicted byarrow J. The analysis device 1 is supplied to a user in this state.

When the protective cap 2 is opened as illustrated in FIG. 1B againstthe engagement with the latch 10 illustrated in FIG. 6A uponspot-application of a sample liquid, a bottom 2 b of the protective cap2 on which the locking groove 12 is formed elastically deforms, causingthe engagement between the locking groove 12 of the protective cap 2 andthe latch 10 of the diluent container 5 to be released as illustrated inFIG. 6B.

In this case, a sample liquid is spot-applied to an exposed inlet 13 ofthe analysis device 1 and the protective cap 2 is closed. At this point,by closing the protective cap 2, a wall face 14 forming the lockinggroove 12 abuts a face 5 b of the latch 10 of the diluent container 5 ona side of the protective cap 2 and pushes the diluent container 5 in thedirection of the arrow J (in a direction approaching the liquiddischarge position). An opening rib 11 a is formed on the diluentcontainer containing section 11 as a protrusion from a side of the basesubstrate 3. When the diluent container 5 is pushed by the protectivecap 2, as illustrated in FIG. 6C, the aluminum seal 9 applied on theseal face of the inclined opening 7 of the diluent container 5 collideswith and is broken by the opening rib 11 a.

A component analysis of a sample liquid can be performed by setting theanalysis device 1 onto a rotor 101 of an analysis apparatus 100 with thecover substrate 4 facing downwards as illustrated in FIGS. 7 and 8.

A groove 102 is formed on an upper face of the rotor 101. When theanalysis device 1 is set on the rotor 101, the engaging section 15formed on the cover substrate 4 of the analysis device 1 and an engagingsection 16 formed on the protective cap 2 engages the groove 102 and theanalysis device 1 is contained.

After setting the analysis device 1 on the rotor 101, when a door 103 ofthe analysis apparatus is closed before rotating the rotor 101, amovable piece 104 provided on a side of the door 103 pushes a positionof the set analysis device 1 on the rotation axial center of, the rotor101 towards the rotor 101 using a biasing force of a spring 105, therebycausing the analysis device 1 to integrally rotate with the rotor 101that is rotationally driven by a rotational driving unit 106. Referencenumeral 107 denotes an axial center during rotation of the rotor 101.The protective cap 2 is attached in order to prevent sample liquidadhering to a vicinity of the inlet 13 from scattering to the outsidedue to centrifugal force during an analysis.

Resin material with low material cost and superior mass productivity isdesirably used for the parts that make up the analysis device 1. Sincethe analysis apparatus 100 analyzes sample liquids using an opticalmeasurement method in which light transmitted through the analysisdevice 1 is measured, a synthetic resin with a high transparency such asPC, PMMA, AS, MS, and the like is desirably used as the material for thebase substrate 3 and the cover substrate 4.

In addition, since it is required that the diluent 8 be sealed insidethe diluent container 5 over a long period of time, a crystallinesynthetic resin with a low moisture permeability such as PP and PE isdesirably used as the material of the diluent container 5. As for thematerial of the protective cap 2, any material with good moldabilityshall suffice. Inexpensive resins such as PP and PE are desirable.

The bonding between the base substrate 3 and the cover substrate 4 isdesirably performed using a method that is unlikely to affect thereaction activity of reagents held in the containment areas. Desirablemethods include ultrasonic welding and laser welding which are lesslikely to create reactive gases or solvents during bonding.

In addition, a portion for transferring a solution by a capillary forceof a minute gap between the base substrate 3 and the cover substrate 4formed by the bonding of the two substrates 3 and 4 is subjected to ahydrophilic treatment to enhance capillary force. Specifically, ahydrophilic treatment using a hydrophilic polymer or a surfactant isperformed. In this case, hydrophilicity refers to a contact angle ofless than 90 degrees with respect to water, and more favorably, acontact angle of less than 40 degrees.

FIG. 9 illustrates a configuration of the analysis apparatus 100.

The analysis apparatus 100 is made up of: a rotation driving unit 106for rotating the rotor 101; an optical measurement unit 108 foroptically measuring a solution in the analysis device 1; a control unit109 that controls the rotational speed and rotational direction of therotor 101, the measurement timing of the optical measurement unit, andthe like; a computing section 110 for processing a signal obtained bythe optical measurement unit 108 and computing a measurement result; anda displaying section 111 for displaying a result obtained by thecomputing section 110.

In addition to rotating the analysis device 1 around the rotation axialcenter 107 via the rotor 101 in any direction at a predeterminedrotational speed, the rotation driving unit 106 is arranged so as to becapable of causing the analysis device 1 to perform a left-rightreciprocating movement centered around the rotation axial center 107 ata predetermined stop position and at a predetermined amplitude range andfrequency so as to swing the analysis device 1.

The optical measurement unit 108 includes: a light source 112 forirradiating light to a measurement section of the analysis device 1; anda photodetector 113 that detects a light intensity of transmitted lighthaving passed through the analysis device 1 among the light irradiatedfrom the light source 112.

The analysis apparatus 100 is arranged such that, by rotationallydriving the analysis device 1 by the rotor 101, a sample liquid or asolution taken inside from the inlet 13 is transferred inside theanalysis device 1 by a centrifugal force that is generated by rotatingthe analysis device 1 around the rotation axial center 107 positionedcircumferentially inward from the inlet 13 and by a capillary force of acapillary channel provided inside the analysis device 1. A microchannelstructure of the analysis device 1, together with analysis processes,will now be described in detail.

FIG. 10 illustrates a vicinity of the inlet 13 of the analysis device 1.

FIG. 10A is an enlarged view of the inlet 13 as seen from the outside ofthe analysis device 1, and FIG. 10B is an enlarged view of themicrochannel structure as seen through the cover substrate 4 from a sideof the rotor 101.

The inlet 13 is connected via a guide section 17 formed between the basesubstrate 3 and the cover substrate 4 and having a minute gap δ at whicha capillary force acts to a capillary cavity 19 that is a gap at which acapillary force acts in the same manner as the guide section 17 andwhich has a volume capable of holding a necessary amount of a sampleliquid 18. Instead of being a rectangular shape whose back end-side isvertical, a cross-sectional shape (a D-D cross section illustrated inFIG. 10B) perpendicular to a flow direction of the guide section 17 isformed by an inclined face 20 that gradually narrows towards a back endthereof in the direction of the cover substrate 4 as illustrated in FIG.10C. A bent section 22 that forms a recess 21 on the base substrate 3and alters the direction of a passage is formed at a connected portionbetween the guide section 17 and the capillary cavity 19.

Seeing from the guide section 17, a separation cavity 23 with a gap atwhich capillary force does not act is formed via and beyond thecapillary cavity 19. A cavity 24 whose one end is connected to theseparation cavity 23 and the other end opened to the air is formed to aside of the capillary cavity 19 and parts of the bent section 22 and theguide section 17.

Due to such a configuration, when spot-applied to the inlet 13, thesample liquid 18 is retrieved by the capillary cavity 19 via the guidesection 17. FIG. 11 illustrates a state of the analysis device 1 set onthe rotor 101 after spot application and before rotation. At this point,as described with reference to FIG. 6C, the aluminum seal 9 of thediluent container 5 has already collided with the opening rib 11 a andhas been broken. Reference characters 25 a, 25 b, 25 c, and 25 d denoteair ducts formed on the base substrate 3.

Process 1

The analysis device 1 is set on the rotor 101 in a state where, asillustrated in FIG. 12A, a sample liquid is held in the capillary cavity19 and the aluminum seal 9 of the diluent container 5 has been broken.

Process 2

When the rotor 101 is rotationally driven clockwise (direction depictedby C2) after closing the door 103, the held sample liquid is broken atthe position of the bent section 22. A sample liquid inside the guidesection 17 is discharged into the protective cap 2. The sample liquid 18inside the capillary cavity 19 flows into the separation cavity 23 andis centrifugally separated in the separation cavity 23 into a bloodplasma component 18 a and a blood cell component 18 b as illustrated inFIGS. 12B and 15A. The diluent 8 having flowed out from the diluentcontainer 5 flows into a holding cavity 27 via discharge channels 26 aand 26 b. When the diluent 8 having flowed into the holding cavity 27exceeds a predetermined amount, a surplus of the diluent 8 flows into anoverflow cavity 29 via an overflow channel 28 and further flows into areference measurement chamber 31 via a rib 30 for preventing reflux.

With respect to the diluent container 5, the shape of a bottom on theopposite side to the opening 7 sealed by the aluminum seal 9 is formedby an arc face 32 as illustrated in FIGS. 4A and 4B. At the same time,at the liquid discharge position of the diluent container 5 illustratedin FIG. 12B, the arc face 32 is formed offset by a distance d so that acenter m of the arc face 32 becomes closer to a side of the dischargechannel 26 b than the axial center 107 as illustrated in FIG. 13.Consequently, the diluent 8 having flowed towards the arc face 32 ischanged so as to flow along the arc face 32 and towards the opening 7from the outside (direction depicted by arrow n), and is efficientlydischarged from the opening 7 of the diluent container 5 to the diluentcontainer containing section 11.

Process 3

Next, when the rotation of the rotor 101 is stopped, the blood plasmacomponent 18 a is siphoned by a capillary cavity 33 formed on a wallface of the separation cavity 23 and then flows into a measurementchannel 38 via a capillary channel 37 that communicates with thecapillary cavity 33 as illustrated in FIGS. 14A and 15B, and a fixedquantity is retained. FIG. 15C is a perspective view illustrating thecapillary cavity 33 and a vicinity of the same.

Process 4

When the rotor 101 is rotationally driven counter-clockwise (directiondepicted by C1), as illustrated in FIG. 14B, the blood plasma component18 a held in the measurement channel 38 flows into a measurement chamber40 via a reflux-preventing rib 39. In addition, the diluent 8 in theholding cavity 27 flows into the measurement chamber 40 via asiphon-shaped connecting channel 41 and the reflux-preventing rib 39.Furthermore, a sample liquid in the separation cavity 23 flows into anoverflow cavity 36 via a siphon-shaped connecting channel 34 and areflux-preventing rib 35. Subsequently, as necessary, the rotor 101 isreciprocatively rotationally moved counter-clockwise (direction depictedby C1) and clockwise (direction depicted by C2) in a swinging motion toagitate a measurement object solution made up of a reagent, the diluent8, and the blood plasma component 18 a held in the measurement chamber.

Process 5

The rotor 101 is rotated counter-clockwise (direction depicted by C1) orclockwise (direction depicted by C2). A reference value is determinedwhen the computing section 110 reads a detected value of thephotodetector 113 at a timing where a measurement spot of the referencemeasurement chamber 31 passes between the light source 112 and thephotodetector 113. Furthermore, the computing section 110 reads adetected value of the photodetector 113 at a timing where a measurementspot of the measurement chamber 40 passes between the light source 112and the photodetector 113 to calculate a specific component based on thereference value.

As seen, since a user can open the diluent container 5 and transfer adiluted liquid into the analysis device 1 by an opening/closingoperation of the protective cap 2 when collecting a sample liquid, ananalysis apparatus can be simplified, cost can be reduced, and useroperability can be improved.

Furthermore, since the diluent container 5 sealed by the aluminum seal 9as a seal member is used and the diluent container 5 is opened bybreaking the aluminum seal 9 with the opening rib 11 a as a protrusion,a diluent does not evaporate and decrease even during long-termpreservation, thereby enabling improvement in analytical precision to berealized.

Moreover, in a shipping state of the analysis device 1 illustrated inFIG. 6A, the latch 10 of the diluent container 5 engages the lockinggroove 12 of the closed protective cap 2 and the diluent container 5 islocked at the liquid holding position and prevented from moving in thedirection of arrow J. Although the diluent container 5 is arranged so asto be movable in the diluent container containing section 11 by anopening/closing operation of the protective cap 2, the position of thediluent container 5 at the diluent container containing section 11 islocked at the liquid holding position until the user opens theprotective cap 2 to use the diluent container 5. As a result, anaccidental opening of the diluent container 5 and spillage of thediluent during transport by the user prior to use can be prevented.

FIG. 16 illustrates a manufacturing process in which the analysis device1 is set to the shipping state illustrated in FIG. 6A. First, beforeclosing the protective cap 2, a groove 42 (refer to FIGS. 2B and 4D)provided on a lower face of the diluent container 5 and a hole 43provided on the cover substrate 4 are aligned. At this liquid holdingposition, a protrusion 44 a of a locking jig 44 provided separate fromthe base substrate 3 or the cover substrate 4 is brought into engagementwith the groove 42 of the diluent container 5 through the hole 43,thereby setting the diluent container 5 in a state where the diluentcontainer 5 is locked at the liquid holding position. Subsequently, apressing jig 46 is inserted through a notch 45 (refer to FIG. 1) formedon an upper face of the protective cap 2 so as to press the bottom faceof the protective cap 2 to cause elastic deformation. In thiselastically deformed state, the analysis device 1 can be set to thestate illustrated in FIG. 6A by closing the protective cap 2 and thenreleasing the pressing jig 46.

In the present embodiment, a case where the groove 42 is provided on alower face of the diluent container 5 has been described as an example.Alternatively, the groove 42 may be provided on an upper face of thediluent container 5, and the hole 43 may be provided on the basesubstrate 3 so as to correspond to the groove 42, whereby the protrusion44 a of the locking jig 44 is to be brought into engagement with thegroove 42.

In the embodiment described above, the locking groove 12 of theprotective cap 2 directly engages the latch 10 of the diluent container5 to lock the diluent container 5 at the liquid holding position.Alternatively, the diluent container 5 may be locked at the liquidholding position by having the locking groove 12 of the protective cap 2and the latch 10 of the diluent container 5 indirectly engage eachother.

In the embodiment presented above, a case has been described as anexample in which a component centrifugally separated from a sampleliquid by rotating the analysis device 1 around the rotation axialcenter 107 and the diluent 8 discharged from the diluent container 5 aretransferred to the measurement chamber 40 to be diluted, wherebyanalysis is performed by accessing a solution component separated from asample liquid or a reactant of a solution component separated from asample liquid and a reagent. However, when a solution component need notbe separated from a sample liquid, the separation process is no longerrequired. In this case, the analysis device 1 is rotated around therotation axial center 107 to transfer all of a fixed amount of a sampleliquid among a spot-applied sample liquid and the diluent 8 dischargedfrom the diluent container 5 to the measurement chamber 40 to bediluted, whereby analysis is performed by accessing a solution componentdiluted by the diluent or a reactant of a solution component diluted bythe diluent and a reagent.

Alternatively, the analysis device 1 may be rotated around the rotationaxial center 107 to transfer a solid component separated from a sampleliquid and a diluent discharged from the diluent container 5 to themeasurement chamber to be diluted, whereby analysis may be performed byaccessing the solid component separated from the sample liquid or areactant of the solid component separated from the sample liquid and areagent.

In the embodiment described above, an analysis device main body having,formed inside, a microchannel structure with minute surfaceirregularities is structured with two layers, namely, the base substrate3 and the cover substrate 4. Alternatively, the analysis device mainbody may be structured by pasting together three or more substrates.Conceivable specific examples include a three-layer structure that is amicrochannel structure formed by setting a substrate notched accordingto a microchannel structure at center, pasting separate substrates on anupper face and a lower face of the central substrate, and closing thenotches.

In FIG. 8, the set analysis device 1 is merely pushed to a side of therotor 101 by the spring 105 set between the door 103 and the movablepiece 104. Therefore, there is a risk that the analysis device 1 maybecome detached from the rotor 101 when an external force acting duringoperation causes an uplift of the analysis device 1 beyond a permissiblevalue. According to second to seventh embodiments described below,situations where the analysis device 1 detaches from the rotor 101 canbe avoided.

Second Embodiment

FIGS. 17 to 19A and 19B illustrate a second embodiment of the presentinvention.

FIGS. 17 to 19A and 19B illustrate an analysis apparatus including ananalysis device driving apparatus according to the present invention.

FIG. 17 illustrates a state where an analysis device 1 according to anembodiment of the present invention is set on a rotor 101 of an analysisdevice driving apparatus of an analysis apparatus. FIGS. 1A and 1Brespectively illustrate a closed state and an opened state of aprotective cap 2 of the analysis device 1. FIG. 2 illustrates anexploded state where a face of the analysis device 1 in contact with therotor 101 is faced upwards. FIG. 3 is a perspective view as seen frombehind of the analysis device in a state where the protective cap 2 isclosed.

The analysis device 1 is made up of parts including: a protective cap 2for preventing scattering of a sample liquid; a base substrate 3 onwhich is formed a microchannel structure having minute irregularities ona surface thereof; a cover substrate 4 covering a surface of the basesubstrate 3; and a diluent container 5 holding a diluent.

The base substrate 3 and the cover substrate 4 are bonded in a statewhere the diluent container 5 and the like are internally set, wherebythe protective cap 2 is attached to the base substrate 3 and the coversubstrate 4 in the bonded state. One side of the protective cap 2 ispivotally supported so as to be capable of engaging shafts 6 a and 6 bformed on the base substrate 3 and the cover substrate 4 and to beopenable and closable.

By covering the openings of several depressions formed on the upper faceof the base substrate 3 with the cover substrate 4, a plurality ofcontainment areas and channels interconnecting the containment areas areformed (refer to FIG. 2). Among the containment areas, those requiredhold, in advance, reagents necessary for performing various analyses.

The analysis device 1 is capable of collecting a sample liquid such asblood and other solutions from an inlet 13, and by closing theprotective cap 2 and setting the sample liquid on the rotor 101 of theanalysis apparatus, a component analysis of the sample liquid can beperformed. Reference numeral 107 denotes an axial center during rotationof the rotor 101.

The analysis device 1 is arranged so as to internally transfer a sampleliquid or a solution taken inside from the inlet 13 by a centrifugalforce that is generated by rotating the analysis device 1 around theaxial center 107 positioned circumferentially inward from the inlet 13and by a capillary force of a capillary channel provided inside theanalysis device 1. The protective cap 2 is attached in order to preventthe sample liquid adherent to a vicinity of the inlet 13 from scatteringto the outside due to centrifugal force during analysis.

Since the aforementioned analysis apparatus analyzes sample liquidsusing an optical measurement method in which light transmitted throughthe analysis device 1 is measured, a resin with a high transparency suchas PC, PMMA, AS, MS, and the like is desirably used as the material forthe base substrate 3 and the cover substrate 4.

Bonding between the base substrate 3 and the cover substrate 4 isdesirably performed using a method that is unlikely to affect thereaction activity of reagents held in the containment areas. Desirablemethods include ultrasonic welding and laser welding which are lesslikely to create reactive gases or solvents during bonding.

FIG. 18 is a more detailed external view of the analysis apparatusillustrated in FIG. 7 and illustrates a state where the door 103 hasbeen opened and the rotor 101 has been exposed so as to enable theanalysis device 1 to be set. FIG. 17 is a cross-sectional view of FIG.18. The door 103 rotationally moves around a support shaft 114 and isopenable and closable.

In this case, a motor 106 a is used as a rotation driving unit 106 torotate the rotor 101 around the axial center 107.

While an arrangement is provided in which rotational operations andswinging operations of the analysis device 1 are performed by a singlerotation driving unit 106, a driving unit for swinging operations may beseparately provided in order to reduce the load on the rotation drivingunit 106. Specifically, by bringing a vibration-applying unit such as avibration motor prepared separate from the motor 106 a into direct orindirect contact with the analysis device 1 set on the rotor 101, theanalysis device 1 is subjected to a swinging motion so as to applyinertial force to the solution in the analysis device 1.

A clamper 116 is held by the door 103 via a holding plate 115. Inaddition, a flat spring 117 as a biasing unit for pressing the clamper116 is provided on the door 103. After setting the analysis device 1 onthe rotor 101, when the door 103 of the analysis apparatus is closed asdepicted by a solid line in FIG. 17 before rotating the rotor 101, theflat spring 117 comes into contact with the clamper 116 on the axis ofthe rotation axial center 107 of the rotor 101, the clamper 116 ispressed to a side of the rotor 101 by a biasing force of the flat spring117, the analysis device 1 is sandwiched by the clamper 116 and therotor 101, and the rotor 101 rotates at high-speed integrally with theanalysis device 1.

At this point, if X1 denotes an engagement depth of a groove 102 of therotor 101 and an engaging section 15 of the analysis device 1, theanalysis device 1 being rotationally driven at high speed is biased to aside of the rotor 101 by the biasing force of the flat spring 117 so asto prevent uplift of the analysis device 1 from the rotor 101 beyond X1.Furthermore, in the present embodiment, a protrusion 119 that sets a gap118 between the door 103 and the flat spring 117 at a position on theaxial center 107 to or below X1 is formed on an inner face of the door103.

As shown, the protrusion 119 as a stopper unit on the door 103 isarranged so as to oppose the flat spring 117, with the gap 118 providedbetween the protrusion 119 and the flat spring 117. Therefore, when anappropriate biasing force is being obtained from the flat spring 117,the protrusion 119 and the flat spring 117 do not come into contact witheach other and the clamper 116, being only in point contact with theflat spring 117 on the axial center 107, rotates at high speed.

On the other hand, even when an external force acts during operation andthe analysis device 1 attempts to uplift from the rotor 101 beyond X1that is a permissible value, the clamper 116 abuts to the protrusion 119via the flat spring 117 and reliably regulates the analysis device 1from detaching from the rotor 101. In this case, contact points betweenthe flat spring 117 and the protrusion 119 are limited to only the pointcontact on the axial center 107. Therefore, a stable operation can beexpected over a long period of time.

Moreover, by arranging the holding plate 115 disposed opposing the setanalysis device 1 as a heater plate that is heated when receiving poweror by indirectly heating the holding plate 115 with a heater, areduction in analysis time can be realized. At the same time, since theneed to dispose a heating unit at a separate location can be eliminated,downsizing of an analysis apparatus can be realized.

X1 described above will now be explained in greater detail withreference to FIGS. 19A and 19B.

FIG. 19A illustrates a state immediately before mounting the analysisdevice 1 on the rotor 101. In order to enable the analysis device 1 tobe easily set in a groove 102 of the rotor 101, an inclined face 120inclined such that a major axis thereof is oriented circumferentiallyoutward is formed at an opening of the groove 102 formed on the rotor101, and an engaging section 15 of the cover substrate 4 of the analysisdevice 1 and an engaging section 16 formed on the protective cap 2 arerespectively processed into chamfered sections 121 and 122 so as toremove circumferentially outermost corners of the engaging section 15and the engaging section 16.

Even when the analysis device 1 is set from a position slightlylaterally offset with respect to the groove 102 of the rotor 101, thechamfered sections 121 and 122 of the analysis device 1 abut to theinclined face 120 of the rotor 101, and the engaging sections 15 and 16of the analysis device 1 are guided by the inclined face 120 of therotor 101 to engage the groove 102 as illustrated in FIG. 19B.

In this case, aforementioned X1 denotes a distance between a position P1of a smallest diameter of the inclined face 120 of the rotor 101 and aproximal end position P2 of the chamfered sections 121 and 122 of theanalysis device 1. In a state where an external force acts duringoperation and the analysis device 1 uplifts from the rotor 101 by X1,the chamfered sections 121 and 122 of the analysis device 1 run on theinclined face 120 of the rotor 101, resulting in a situation where theanalysis device 1 becomes detached from the rotor 101 due to centrifugalforce. Therefore, the clamper 116 must be maintained so that the clamper116 does not uplift from the rotor 101 beyond the permissible value X1against the biasing force of the flat spring 117.

Third Embodiment

In the second embodiment, a protrusion 119 as a stopper unit is formedon the door 103 in order to regulate an uplift of the analysis device 1from the rotor 101. In a third embodiment illustrated in FIG. 20, a gap123 between an opposing face 115A of a holding plate 115 which opposes aclamper 116 and the clamper 116 is set smaller than a permissible valueX1. Otherwise, the configuration is the same as the configuration of thesecond embodiment illustrated in FIG. 17.

A hole 115B that is smaller in diameter than a large diameter section116A and a small diameter section 116B of the clamper 116 is formed atthe center of the holding plate 115. The clamper 116 is supported byinserting a body section 116C between the large diameter section 116Aand the small diameter section 116B into the hole 115B.

Fourth Embodiment

In the third embodiment, the clamper 116 is directly abutted to a lowerface of the holding plate 115 in order to regulate uplift of theanalysis device 1 from the rotor 101 due to external force. However, ina fourth embodiment illustrated in FIG. 21, a protrusion 124 thatprotrudes towards a clamper 116 is formed around the hole 115B on a faceof the holding plate 115 on a side of the rotor 101, and a gap 125between the protrusion 124 and the clamper 116 is set smaller than apermissible value X1. Otherwise, the configuration is the same as theconfiguration of the second embodiment illustrated in FIG. 17.

Specifically, the protrusion 124 is formed by a material that issuperior in friction and abrasion characteristics than the holding plate115 such as POM (polyacetal) and nylon.

Fifth Embodiment

In the third embodiment, the clamper 116 is directly abutted to a lowerface of the holding plate 115 in order to regulate uplift of theanalysis device 1 from the rotor 101 due to external force. However, ina fifth embodiment illustrated in FIG. 22, a protrusion 126 is formed onan opposing face of a small diameter section 116B of a clamper 116 whichopposes the holding plate 115, and a gap 127 between the protrusion 126and the holding plate 115 is set smaller than a permissible value X1.Otherwise, the configuration is the same as the configuration of thesecond embodiment illustrated in FIG. 17.

Specifically, the protrusion 126 is formed integrally with the smalldiameter section 116B by a material that is superior in friction andabrasion characteristics than the holding plate 115 such as POM(polyacetal) and nylon.

Sixth Embodiment

While the biasing unit in the respective embodiments described above isthe flat spring 117, a coil spring can be used instead.

FIG. 23 illustrates a modification of FIG. 20. A description will now begiven, wherein parts similar to preceding embodiments are assignedsimilar reference characters.

In the present sixth embodiment, a clamper 116 is fixed via a bearing129 to a tip of a shaft 128 implanted on a door 103. Reference numeral130 denotes a retaining ring provided so as to prevent the bearing 129from dropping off from the shaft 128. A coil spring 132 is set betweenthe door 103 and a washer 131 whose one face touches an innercircumferential side of the bearing 129. In a state where the door 103is opened to a position depicted by an imaginary line, the clamper 116is pushed against the ring 130 on the tip of the shaft 128 by the coilspring 132. The shaft 128 is inserted through an inner side of the coilspring 132.

In a state where the door 103 is closed to a position depicted by asolid line and the analysis device 1 is sandwiched by the rotor 101 andthe clamper 116, the bearing 129 is separated from the ring 130 againstthe biasing of the coil spring 132. Therefore, the clamper 116 ispressed against the analysis device 1 set on the rotor 101 by thebiasing force of the coil spring 132 and held in this state.

On the other hand, even when the analysis device 1 attempts to upliftitself from the rotor 101 by more than X1 that is a permissible value,since a gap 134 between a protrusion 133 integrally formed with the door103 and the washer 131 during normal operation is set smaller than thepermissible value X1, the washer 131 strikes the protrusion 133 of thedoor 103 first when the analysis device 1 uplifts from the rotor 101 dueto an action of an external force during operation. As a result, asituation such as the analysis device 1 detaching itself from the rotor101 can be avoided. The protrusion 133 is formed on the door 103 so asto surround the shaft 128.

Seventh Embodiment

In the respective embodiments described above, the door 103 is opened tomount the analysis device 1 on the rotor 101, and by closing the door103 in this state, the analysis device 1 is sandwiched by the rotor 101and the clamper 116. However, a case where the analysis device 1 issandwiched by the rotor 101 and the clamper 116 by a central loadingsystem as illustrated in FIGS. 24 and 25 can also be implemented.

In the present embodiment, when a leading end of the analysis device 1is inserted into an insertion opening 136 formed on a front panel 135 ofa chassis 137 of an analysis apparatus, a handling unit (not shown)having detected that the analysis device 1 has been inserted into theinsertion opening 136 sets the analysis device 1 inserted into theinsertion opening 136 on a rotor 101 that is standing by at a descendedposition.

A configuration of the handling unit is the same as the configurationsof optical disk drive apparatuses that adopt a front loading system.More specifically, a configuration of this type is described in JapanesePatent Laid-Open No. 10-027407.

When the handling unit finishes setting the analysis device 1 on therotor 101 as illustrated in FIG. 25A, the rotor 101 then rises asillustrated in FIG. 25B to sandwich the analysis device 1 with theclamper 116. Otherwise, the configuration is the same as the secondembodiment.

Moreover, the third to sixth embodiments can also be implemented with afront loading system.

Furthermore, the analysis device 1 is desirably provided with a lockingmechanism so as to prevent a protective cap 2 of the analysis device 1during analysis from being opened due to centrifugal force or to preventa protective cap 2 of a used analysis device 1 from being reopened.Specific examples thereof will now be described based on eighth totwelfth embodiments.

Eighth Embodiment

FIGS. 28 to 34 illustrate an eighth embodiment of the present invention.

A lidded container represents a case of an analysis device to be usedfor sampling a liquid considered to be an infectious material such asblood and setting the same on an analysis apparatus.

FIG. 28 illustrates an analysis device 1 including a locking mechanism.In the analysis device 1, an end of a protective cap 2 as a lid memberis pivotally supported by a shaft 6 a so as to be rotationally movablebetween a position where an inlet 13 as a protection object location isexposed and a position where the inlet 13 is covered (refer to FIG. 31).

The analysis device 1 is supplied to a user with the protective cap 2closed. At the beginning of use, the user opens the protective cap 2 asillustrated in FIG. 28, pierces a fingertip of a testee by a needle andspot-applies blood on the fingertip onto the inlet 13, and after spotapplication of blood, closes the protective cap 2.

Subsequently, the user sets the analysis device 1 on the analysisapparatus 100 as illustrated in FIGS. 18, 29, and 30. FIG. 29illustrates a state where the door 103 is opened and the analysis device1 is to be set. FIG. 30 illustrates a state during rotation where thedoor 103 has been closed and the analysis device 1 is held sandwichedbetween the rotor 101 and the door 103. Reference numeral 150 denotes anoptical reading apparatus to which a light source 112 and aphotodetector 113 are attached so as to oppose each other. In FIG. 28,protrusions 151 a and 151 b on a primary face of the analysis device 1illustrated in FIG. 30 have been omitted.

FIG. 31 illustrates an unused analysis device 1 that has been suppliedto a user.

A device main body 201 as a container main body is formed in the samemanner as in the embodiments described above by pasting together a basesubstrate 3 and a cover substrate 4. A locking piece 201 b as a lockingportion is provided on a primary face 201 a of the device main body 201.A hooked section 202 b is provided on a primary face 202 a of theprotective cap 2. FIG. 32 is a partial enlarged view of the lockingpiece 201 b and the hooked section 202 b at this point. The unused stateis either a state where stress that elastically deforms the hookedsection 202 b is not acting on the hooked section 202 b or a state wherestress that causes elastic deformation is hardly acting on the hookedsection 202 b. Therefore, even when the analysis device 1 has beenpreserved over a long period of time prior to use, a functional declinedue to resin deformation does not occur.

When the protective cap 2 is opened in a direction depicted by an arrowS1 centered around a shaft 6 a of the device main body 201 upon samplingblood, as illustrated in FIGS. 33A and 33B, a tip of the hooked section202 b slides while the hooked section 202 b is being elasticallydeformed in a direction depicted by an arrow S2 along a first slidingface 201 c of the locking piece 201 b of the device main body 201.Eventually, as illustrated in FIG. 33C, the tip of the hooked section202 b detaches from the locking piece 201 b and the elastic deformationis once again released. By fully opening the protective cap 2, asillustrated in FIG. 28, the inlet 13 of the device main body 201 becomesexposed.

When the protective cap 2 is closed in a direction depicted by an arrowS3 centered around a shaft 6 a of the device main body 201 after bloodis spot-applied on the inlet 13, as illustrated in FIGS. 34A and 34B,the hook 202 c slides along a second sliding face 201 d of the lockingpiece 201 b and runs upon the locking piece 201 b, causing the hookedsection 202 b to elastically deform in a direction depicted by an arrowS4. Eventually, as illustrated in FIG. 34C, a hook 202 c on a tip of thehooked section 202 b crosses over the locking piece 201 b, and theelasticity of the hooked section 202 b causes the hook 202 c to engage abottom 201 e of the locking piece 201 b.

As illustrated in FIG. 34C, with the analysis device 1 supplied foranalysis by the analysis apparatus 100 in a locked state where thehooked section 202 b is in engagement with the bottom 201 e of thelocking piece 201 b, even when attempting to reopen the protective cap2, the locked state prevents the protective cap 2 from being easilyopened.

In addition, the activation of the locking mechanism of the protectivecap 2 also prevents the protective cap 2 from being inadvertently openedby centrifugal force during analysis by the analysis apparatus 100, andalso forestalls breakage of the analysis device 1 and the analysisapparatus 100.

After measurement, a used lidded container is desirably discarded assoon as possible. However, even if reuse is accidentally attempted, theprotective cap 2 with a reuse prevention mechanism makes it difficult toopen the lid, thereby preventing secondary infection or blood infectionof the user due to accidental reuse. Lidded containers that primarilycollect blood such as the lidded container described above internallyinclude an electrode for analyzing blood as well as chemicals such as anenzyme, a pigment and a mediator, thereby enabling analysis with asimplified method as a disposable sensor. However, the realization ofreuse prevention need not be limited to the analysis of blood and isalso useful when using lidded containers in regards to health managementusing urine or sweat or in regards to environmental chemical analysis.

A resin material for molding the protective cap 2 must be flexible.While PP, PE, ABS, POM and the like are sufficient in this regard, theresin material need not be limited thereto.

In the present eighth embodiment, a hooked section 202 b is provided onthe protective cap 2 and a locking piece 201 b is provided on the devicemain body 201. Alternatively, the hooked section 202 b may be providedon the device main body 201 and the locking piece 201 b on theprotective cap 2.

Ninth Embodiment

FIGS. 35 to 41 illustrate a ninth embodiment of the present invention.In addition, FIGS. 42 to 44 illustrate a modification.

With the analysis device 1 as a lidded container according to the eighthembodiment, the hooked section 202 b and the locking piece 201 b areprovided on a primary face-side of the analysis device 1. However, inthe present ninth embodiment, as illustrated in FIGS. 35 and 36, ahooked section 202 b and a locking piece 201 b are provided on aperipheral face 220 adjacent to a primary face of an analysis device 1.

FIG. 35 illustrates a state during blood sampling where a protective cap2 has been opened so as to expose an inlet 13. FIG. 36 illustrates astate before the protective cap 2 is opened as illustrated in FIG. 35.

As illustrated in FIG. 37, the hooked section 202 b is formed on aperipheral face of the protective cap 2. An angular protrusion 2 f andfirst and second guide walls 2 g and 2 h are formed on a peripheral faceof a device main body 201.

A cross section A of the protrusion 2 f in a direction that follows arotational movement path of the protective cap 2 is illustrated in FIG.38. The protrusion 2 f is made up of a first inclined face 2 f 1 havingan ascending gradient in a direction that opens the protective cap 2 anda second inclined face 2 f 2 connected to a summit 2 ff of the firstinclined face 2 f 1 and which has a descending gradient in a directionthat opens the protective cap 2.

Formed on the second guide wall 2 h are: an inward guide face 2 h 1facing the first guide wall 2 g; a lateral guide face 2 h 2 formed on anouter peripheral side of the protrusion 2 f with a guide faceorientation differentiated from the second inclined face 2 f 2 of theprotrusion 2 f by 90 degrees; and a recess 2 h 3 formed on an end of thelateral guide face 2 h 2 on a side that is opposite the second inclinedface 2 f 2. The lateral guide face 2 h 2 is gradually inclined from oneend on a side of the second inclined face 2 f 2 towards the recess 2 h 3so as to approach an outer peripheral side of the analysis device 1.

In a state before opening the protective cap 2, as illustrated in FIGS.39 and 40, a hook 202 c on a tip of the hooked section 202 b of theprotective cap 2 has crossed over the first inclined face 2 f 1 of theprotrusion 2 f of the device main body 201 and is stationary. Thisunused state is either a state where stress that elastically deforms thehooked section 202 b is not acting on the hooked section 202 b or astate where stress that causes elastic deformation is hardly acting onthe hooked section 202 b. Therefore, even when the analysis device 1 hasbeen preserved over a long period of time prior to use, a functionaldecline due to resin deformation does not occur.

When the protective cap 2 is opened centered around a shaft 6 a of thedevice main body 201 from this state, the hook 202 c slidingly movesacross the first inclined face 2 f 1 towards the summit, the hookedsection 202 b gradually elastically deforms in a thickness direction ofthe analysis device 1 as illustrated in FIG. 41A, and the hooked section202 b is pushed towards the inner side of the analysis device 1 by theinward guide face 2 h 1 of the second guide wall 2 h and slidingly moveswhile being elastically deformed. When the hook 202 c passes the inwardguide face 2 h 1, the elastic deformation that has been acting on thehooked section 202 b in a direction that pushes the hooked section 202 btowards the inner side of the analysis device 1 is released.Furthermore, as the protective cap 2 is opened, the hook 202 c slidinglymoves across the second inclined face 2 f 2. Eventually, the engagementbetween the hooked section 202 b and the protrusion 2 f is released toenter a state where no stress acts on the hooked section 202 b. Animaginary line J depicts a migration path of the hooked section 202 b atthis point.

Moreover, the second inclined face 2 f 2 acts effectively when closingthe protective cap 2 to set the protective cap 2 to an unused state.

A fingertip of a testee is pierced by a needle. Blood formed on thefingertip is spot-applied onto the inlet 13, and after blood isspot-applied, the protective cap 2 is closed. At this point, the hook202 c on the tip of the protective cap 2 is pushed out circumferentiallyoutward along the lateral guide face 2 h 2 and gradually elasticallydeforms as illustrated in FIG. 41B. Eventually, as illustrated in FIG.41C, the hook 202 c engages the recess 2 h 3 as a locking portion formedon a trailing end position of the lateral guide face 2 h 2 by an elasticforce of the hooked section 202 b. The state illustrated in FIG. 41Crepresents a state where a reuse prevention mechanism has been activatedand reuse cannot be easily performed.

The hooked section 202 b depicted by an imaginary line in FIG. 40represents a state of maximum elastic deformation in a horizontaldirection immediately before the hook 202 c engages the recess 2 h 3.

As seen, when opening the protective cap 2, by running on the protrusion2 f provided on a side of the device main body 201 and creating anelastic deformation in a direction perpendicular to a plane, theprotective cap 2 can be opened with relatively small resistance.

Next, when closing the protective cap 2, the hooked section 202 b isguided by the lateral guide face 2 h 2 and elastically deformshorizontally outwards (direction depicted by arrow S5) centered around aproximal end of the hooked section 202 b, thereby creating a state wherethe hook 202 c engages the recess 2 h 3 and opening is difficult.Consequently, a user is relieved from accidents due to reuse.

With the locking mechanism described in the present ninth embodiment, bycombining movement perpendicular to a plane with movement parallelthereto of the hooked section 202 b which accompany the opening andclosing the protective cap 2, an flexure of the hooked section 202 bfrom the proximal end can be reduced up to 60% as compared to a casewhere a similar function is realized only by planar-direction movement.For example, if a length L1 of the hooked section 202 b is 8 mm, athickness t of the hooked section 202 b is 1 mm, and a distance from theshaft 6 a of the device main body 201 to the hooked section 202 b is 46mm, then an flexure A depicted in FIG. 40 which is 2.5 mm in the case ofthe locking mechanism according to the eighth embodiment can be reducedby 32% to 1.7 mm.

A resin material for molding the protective cap 2 must be flexible.While PP, PE, ABS, POM and the like are sufficient in this regard, theresin material need not be limited thereto.

In the present ninth embodiment, a hooked section 202 b is provided onthe protective cap 2 and a locking piece 201 b is provided on the devicemain body 201. Alternatively, the hooked section 202 b may be providedon the device main body 201 and the locking piece 201 b on theprotective cap 2.

Tenth Embodiment

Next, a modification illustrated in FIGS. 42 to 44 will be described.

In the ninth embodiment illustrated in FIGS. 35 to 41, the protrusion 2f and the first guide wall 2 g are formed on the device main body 201.In contrast, the present tenth embodiment does not include the angularprotrusion 2 f and the first guide wall 2 g illustrated in FIG. 38. Inthe following description, parts performing similar actions are assignedsimilar reference characters to those used in FIGS. 35 to 41.

Specifically, in a state before opening the protective cap 2, asillustrated in FIGS. 42 and 43, a hook 202 c on a tip of a hookedsection 202 b of a protective cap 2 is positioned on an inner side of aninward guide face 2 h 1 of a second guide wall 2 h and is stationary.This unused state is either a state where stress that elasticallydeforms the hooked section 202 b is not acting on the hooked section 202b or a state where stress that causes elastic deformation is hardlyacting on the hooked section 202 b. Therefore, even when the analysisdevice 1 has been preserved over a long period of time prior to use, afunctional decline due to resin deformation does not occur.

When the protective cap 2 is opened centered around a shaft 6 a of adevice main body 201 from this state, the hook 2 c slidingly moves and,as illustrated in FIG. 44A, the hooked section 202 b is pushed towardsthe inner side of the analysis device 1 by the inward guide face 2 h 1and slidingly moves while being elastically deformed. The elasticdeformation in the direction that pushes the hooked section 202 btowards the inner side of the analysis device 1 continues until theabutting of the hook 202 c and the second guide wall 2 h is released.When the hook 202 c passes the inward guide face 2 h 1, the elasticdeformation that has been acting on the hooked section 202 b in thedirection that pushes the hooked section 202 b towards the inner side ofthe analysis device 1 is released.

When closing the protective cap 2, the hook 202 c on the tip of theprotective cap 2 is pushed out in a circumferentially outward directionS5 along a lateral guide face 2 h 2 and gradually elastically deforms asillustrated in FIG. 44B. Eventually, as illustrated in FIG. 44C, thehook 202 c engages a recess 2 h 3 formed on a trailing end position ofthe lateral guide face 2 h 2 by an elastic force of the hooked section202 b.

Eleventh Embodiment

FIGS. 45 to 49 illustrate an eleventh embodiment of the presentinvention.

In the ninth and tenth embodiments, the analysis device 1 as a liddedcontainer has been described using a case where an end of the protectivecap 2 is pivotally supported by the device main body 201 so as to berotationally movable between a position where protection objectlocations of the device main body 201 are covered and a position wherethe protection object locations are exposed. In the present eleventhembodiment, a description will be given on a case of a lidded container300 arranged such that by slidingly moving a protective cap 2 set at aposition where protection object locations of a device main body 201 arecovered along a sliding face between the device main body 201 and theprotective cap 2, the protection object locations enter an exposed stateand become removable.

In order to obtain blood necessary for analysis, a testee pierceshis/her own fingertip using a puncture device to obtain a small amountof blood. The lidded container 300 can hold a plurality of used punctureneedles used with the puncture device during disposal.

As illustrated in FIGS. 45 and 46 or FIG. 49, the protective cap 2 canbe fitted to the outside of an insertion guide 301 formed on anopening-side periphery of the device main body 201 so as to close anopening of the device main body 201.

A locking piece 201 i is formed at a portion of the insertion guide 301of the device main body 201. By forming a notch 202 h on a portion ofthe protective cap 2 in correspondence to the locking piece 201 i, ahooked section 202 d is formed on a face that follows the insertionguide 301.

FIG. 46 illustrates an unused lidded container 300.

In a state before opening the protective cap 2, as illustrated in FIG.47, a first inclined section 202 f of a hook 202 e on a tip of thehooked section 202 d of the protective cap 2 is in engagement with afirst inclined face 201 j of the locking piece 201 i of the device mainbody 201. This unused state is either a state where stress thatelastically deforms the hooked section 202 d is not acting on the hookedsection 202 d or a state where stress that causes elastic deformation ishardly acting on the hooked section 202 d. Therefore, even when thelidded container 300 has been preserved over a long period of time priorto use, a functional decline due to resin deformation does not occur.

When the protective cap 2 is lifted in a direction depicted by an arrowS6 with respect to the device main body 201, the first inclined section202 f of the hook 202 e slidingly moves across the first inclined face201 j of the locking piece 201 i, the hooked section 202 d elasticallydeforms as depicted by an imaginary line, and a tip of the hookedsection 202 d moves outward as depicted by an arrow S7 in FIG. 47.Eventually, the hook 202 e detaches itself from the locking piece 201 i.

When the device main body 201 reaches a fixed quantity with usedpuncture needles and the protective cap 2 is inserted into the devicemain body 201, an inclined bottom 202 g of the hook 202 e of the hookedsection 202 d released from elastic deformation abuts a second inclinedface 201 k formed on an upper face of the locking piece 201 i asillustrated in FIG. 48. As the protective cap 2 is further inserted intothe device main body 201, the bottom 202 g of the hook 202 e slidinglymoves across an upper face of the second inclined face 201 k of thelocking piece 201 i, a tip of the hooked section 202 d elasticallydeforms as depicted by an imaginary line in a direction depicted by anarrow S8, and the hook 202 e moves outward. Eventually, the hookedsection 202 d detaches itself from the locking piece 201 i, and due tothe elastic force of the hooked section 202 d, the hook 202 e engages arecess 201 m of the locking piece 201 i as a locking portion asillustrated in FIG. 49. In the state illustrated in FIG. 49, a reuseprevention mechanism has been activated, thereby making reuseimpossible.

Twelfth Embodiment

FIG. 50 illustrates a twelfth embodiment of the present invention.

In the eleventh embodiment, the hooked section 202 d is integrallyformed by forming the notch 202 h on the protective cap 2. However, in acase of a lidded container 300 illustrated in FIG. 50, a material of ahooked section 202 d differs from a material of a protective cap 2.

Specifically, an arm 202 i of the hooked section 202 d is formed by arod-shaped body from a material that differs from the protective cap 2.A hook 202 e made of resin and having a predetermined shape is coupledto a tip of the arm 202 i. An unused state illustrated in FIG. 50 iseither a state where stress that elastically deforms the arm 202 i isnot acting on the arm 202 i or a state where stress that causes elasticdeformation is hardly acting on the arm 202 i. Therefore, even when thelidded container 300 has been preserved over a long period of time priorto use, a functional decline due to resin deformation does not occur.

As seen, a reuse prevention mechanism can be realized by forming theportion of the arm 202 i which requires flexible elastic deformationusing a material that is more flexible than the protective cap 2 or, inthe case of metal, taking advantage of the characteristics of the metalto come up with a narrow and sinuous structure.

In addition, besides inserting a metallic arm 202 i into the protectivecap 2, a locking mechanism may be realized by forming parts ranging fromthe hook 202 e to the arm 202 i with a material that differs from theprotective cap 2 such as butadiene rubber that is an elastomer, andbonding the parts to the protective cap 2 by fitting or using anadhesive.

In the eleventh and twelfth embodiments, the hooked section 202 d isprovided on the protective cap 2 and the locking piece 201 i is providedon the device main body 201. Alternatively, the hooked section 202 d maybe provided on the device main body 201 and the locking piece 201 i onthe protective cap 2.

In the eleventh and twelfth embodiments, the lidded container 300 hasbeen described as a container for waste disposal. However, the analysisdevice 1 described earlier having a microchannel structure with minutesurface irregularities formed inside the device main body 201 can beimplemented in the same manner.

The present invention can contribute towards the prevention of secondaryinfection that occurs when coming into contact with infectious orhazardous substances and contamination attributable to contaminants.Furthermore, in cases where a lidded container rotates during use, thepresent invention prevents accidental opening due to centrifugal forceas well as breakage of the lidded container, a rotating apparatus, andvarious analysis apparatus. Therefore, improvements in safety can beexpected.

INDUSTRIAL APPLICABILITY

The present invention is useful as a transfer control unit of ananalysis device to be used for component analysis of a liquid collectedfrom a living organism or the like.

The invention claimed is:
 1. A fluid handling device having amicrochannel structure that transfers a sample liquid towards ameasurement spot by a centrifugal force about a rotation axis, the fluidhandling device being used for reading involving accessing a reactionliquid at the measurement spot, the fluid handling device comprising: afluid handling device main body having, formed inside, a microchannelstructure with minute surface irregularities; a protective cap thatexposes, in an open position, an inlet for collecting the sample liquidinto the microchannel structure, and in a closed position, that covers apart of the fluid handling device main body, thereby preventing theinlet from being exposed; a diluent container whose opening is sealed bya seal member so as to internally hold a diluent; a diluent containercontaining section inside the fluid handling device main body, thediluent container containing section holding the diluent container suchthat the diluent container is slidably movable in a transverse directionrelative to the rotation axis between a liquid holding position and aliquid discharge position; a protrusion provided so as to protrude alonga movement path of the diluent container from the liquid holdingposition to the liquid discharge position in the diluent containercontaining section, the protrusion breaking the seal member of thediluent container when the diluent container moves to the liquiddischarge position so as to open the diluent container; a latchpositioned at a side of the dilute container facing the protective cap;and a locking groove formed on the protective cap, the locking groovebeing engaged to the latch when the diluent container is positioned inthe liquid holding position so as to prevent the diluent container frommoving toward the liquid discharge position, wherein the latch and thelocking groove are disengaged by a shifting of the protective cap fromthe closed position to the open position, and wherein a wall face facingthe diluent container is formed on the protective cap next to thelocking groove, when the protective cap shifts from the open position tothe closed position, the wall face abuts a face of the latch that facesthe protective cap and pushes the diluent container from the liquidholding position to the liquid discharge position, thereby allowing theprotrusion to collide with the seal member and break the seal member. 2.The fluid handling device according to claim 1, wherein a seal face onwhich the seal member of the diluent container is to be attached isformed inclined.
 3. A fluid handling method utilizing the fluid handlingdevice according to claim 1, the fluid handling method comprising:spot-applying the sample liquid onto the inlet exposed by opening theprotective cap of the fluid handling device and collecting the sampleliquid; pushing the diluent container positioned in the diluentcontainer containing section of the fluid handling device towards theprotrusion by an operation of the protective cap from the open positionto the closed position; pressing the seal member of the diluentcontainer against the protrusion so as to break the seal member and openthe diluent container; and setting the fluid handling device onto arotor having a rotation axis and rotating the rotor so as to dilute atleast a portion of the sample liquid spot-applied to the fluid handlingdevice by the diluent discharged from the diluent container.
 4. Thefluid handling device according to claim 1, wherein the latch isintegral with the dilute container.